PDA 178.1 ICH Q2 and Q3 – A Lifecycle Approach to Method Development, Method Validation and Impurity Testing

The first three ICH quality guidelines have laid the foundation for many guidances from regulatory agencies globally and continue to provide the cornerstone of validation of analytical procedure to monitor product quality.

ICH Q1A(R2) introduces the concept of climatic zones to recognize the significant different of storage conditions of worldwide market. It lays out the minimum requirements of the body of analytical data needed to establish the expiry of new drug substance and drug product. It also explains the role of stress testing and accelerated testing to establish stability profile of product being studied.

The validation goal of ICH Q2(R1) is to build a framework that demonstrates that the method is reliable to monitor the quality of the product at the present time while anticipating future changes to maintain the validity of the procedure throughout the product’s lifecycle.

The ICH Q3 guidelines discussing impurities in drug substances and drug product have been accepted and used broadly for many years. They lay out a stable landscape for classifying and monitoring impurities. These guidelines introduced early on the concept of risk-based impurity specifications. The industry and regulators established guidelines that introduced an acceptable level of quality with impurities allowed at levels demonstrated to not be toxic. Q3A and Q3B emphasize the monitoring and controls required for organic impurities.

These guidelines are linked to USP General Chapter <476> and <1086> to provide guidances to handle impurities of pharmaceutical products. The risk-based impurity limit concept was further developed with the introduction of ICH Q3C – Residual Solvents and later with ICH Q3D – Elemental Impurities.

This live eLearning training course will discuss the requirements of ICH Q2 and Q3A/B on organic impurities and different thresholds to monitor them in the Active Pharmaceutical Ingredients or Drug Products. Concept of Quality by Design (QbD) will also be discussed and applied to the development of analytical procedures including the key factors to be considered through the product lifecycle.

1. Understand validation objectives from ICH Q2(R1) and USP General Chapter <1225>
2. Outline changes emphasized in 2015 FDA analytical method validation guidance
3. Express different thresholds to monitor organic impurities in API and finished products based on ICH Q3
4. Apply concept of risk-based management of impurities described in ICH Q3C, Q3D and M7
5. Establish body of data required to justify an expiry and establish stress and accelerated testing conditions to understand the degradation mechanism and support distribution based on ICH Q1A(R2)
6. Discuss current FDA initiatives on Method Validation to support product lifecycle